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FORNY20-FORNY2020

KVAL: Development of the next generation antibody therapy for the treatment of CD37+ B-cell diseases

Alternative title: Utvikling av neste generasjons antistoffterapi for behandling av CD37+ B-cellesykdommer

Awarded: NOK 0.50 mill.

Monoclonal antibodies have a clinical approval rate twice that of small molecular drug entities. The reasons for this are that they are specific, long-acting and cause limited side effects. Currently, about 600 antibody candidates are at various clinical phases. This clinical success has spurred a great interest in development of next-generation of antibodies with more fit-for-purpose binding and transport properties. The rationale is to direct the designed antibodies to the site of action and to fine-tune the induction of potent effector functions. Importantly, despite the reasonably long half-lives of IgG antibodies, market pressures and patients need for higher convenience and compliance continue to drive antibody drug development programs toward less frequent dosing schedules and subcutaneous administration. We have developed a new antibody technology that can be used to tailor-design the next-generation of monoclonal IgG antibodies for improved pharmacokinetic and effector function properties. In this qualification project, we have combined the technology with one particular lead IgG antibody candidate targeting B cell driven diseases. Here, we have conducted a set of key experiments that have demonstrated the advantage of the technology in the context of this lead monoclonal antibody. Based on the promising data, a patent application will very soon be submitted. In addition, in collaboration with an industrial partner we are performing additional experiments, which may lead to a license agreement.

The project has led to a conclusive set of data on benchmarking of our unique antibody technology for a lead antibody candidate. The results obtain fully support the benefits of the technology, which will be part of a patent application soon to be submitted. A collaborative agreement with an industrial partner has just been signed, and a preclinical therapy study has been initiated. If successful, this may lead to a license agreement with a clinical-stage company with a tailored commercialization strategy. This may provide an attractive alternative for treatment of patients with aggressive and indolent non-Hodgkin lymphomas, bit also a range of other B cell driven diseases.

We have developed a new antibody Fc technology platform (REW) that can be used to tailor-design the next-generation of monoclonal IgG antibodies for improved pharmacokinetic and effector function properties. The technology is versatile as it can be combined with any IgG antibody directed toward a range of indications. In this qualification project, we will combine the technology with one particular lead IgG antibody candidate with specificity for CD37 (REW37), a relevant target for a range of B cell driven diseases. We seek funding to conduct a set of key experiments to determine the advantages of the Fc technology in the context of a lead anti-CD37 IgG1 monoclonal antibody. If the project is successful, this will trigger a license agreement with Nordic Nanovector who will further develop and commercialize the anti-CD37 REW Fc antibody.

Funding scheme:

FORNY20-FORNY2020